Spinal catheter having multiple obstruction-clearing features

Abstract

A spinal catheter for insertion into the epidural space of a human or animal subject includes first and second lumens. A pressurized fluid can be discharged through the first lumen directly onto a tissue obstruction to form a partial/pilot or full/final opening in the tissue obstruction. If a full opening was not formed sufficient for passage of the stimulator lead, the distal-end portion of the stimulator lead can be inserted into the partial opening and then a pressurized fluid can be delivered through the second lumen and into a distensible balloon for expanding the balloon to clear the tissue obstruction sufficient for passage of the stimulator lead. In this way the catheter can be advanced past a tissue obstruction and into place for use within the epidural space, without having to remove and reinsert multiple surgical implements.

What is claimed is: 
     
         1 . A spinal catheter for inserting into an epidural space of a human or animal subject, the epidural space having a treatment area and a tissue obstruction, the catheter comprising:
 a shaft defining a longitudinal axis and including a main extension portion and a distal-end portion, wherein the distal-end portion is positioned distally of the main portion and has a distal tip, and wherein at least a portion of the shaft is flexible;   a first lumen extending through at least a portion of the shaft and including a first outlet in the distal tip of the shaft, wherein the first lumen carries a first pressurized fluid and the first outlet discharges the first pressurized fluid directly onto the tissue obstruction to pressure-ablate at least a pilot opening therein;   a second lumen extending through at least a portion of the shaft and including a second outlet in the shaft, wherein the second lumen carries a second pressurized fluid and the second outlet discharges the second pressurized fluid; and   a distensible balloon positioned at the distal-end portion of the shaft, in fluid communication with the second outlet, and positionable within the pilot opening in the tissue obstruction, wherein delivery of the second pressurized fluid into the balloon inflates the balloon within the pilot opening to radially compress the tissue obstruction to enlarge the pilot opening to form a final opening in the tissue obstruction through which the main portion of the shaft can pass so that the first outlet of the first lumen can be advanced to the treatment area in the epidural space,   wherein the distal-end portion of the shaft has a smaller diameter than the main portion, wherein the catheter can be guided forward until the balloon is positioned within the pilot opening in the tissue obstruction by advancing into the pilot opening at least a portion of the distal-end portion and the balloon but not the main portion of the shaft.   
     
     
         2 . The catheter of  claim 1 , wherein the first and second pressurized fluids can be delivered through the first and second lumens, respectively, to displace the tissue obstruction, and the catheter can be used to insert endoscopic surgical instruments, or to deliver or drain a third fluid, through the first lumen to or from the treatment area in the epidural space, all without removing and reinserting the catheter relative to the epidural space. 
     
     
         3 . The catheter of  claim 1 , wherein exhausting the second pressurized fluid from the distensible balloon, through the second lumen of the shaft, deflates the balloon. 
     
     
         4 . The catheter of  claim 1 , further comprising a stylet for guiding through the first lumen to guide insertion of the catheter within the epidural space. 
     
     
         5 . The catheter of  claim 1 , wherein the catheter can be guided into place within the epidural space using fluoroscopy. 
     
     
         6 . The catheter of  claim 1 , wherein the first pressurized fluid includes a saline solution, corticosteroid, and hyaluronidase. 
     
     
         7 . The catheter of  claim 1 , wherein the second pressurized fluid comprises a sterilized fluid under sufficient pressure to inflate the balloon. 
     
     
         8 . The catheter of  claim 1 , wherein the catheter is a percutaneous lead, a surgical lead, or a spinal cord stimulator lead. 
     
     
         9 . The catheter of  claim 1 , wherein the second lumen for inflating the balloon against the tissue obstruction has a smaller diameter than the first lumen for discharging the first pressurized fluid directly onto the tissue obstruction. 
     
     
         10 . The catheter of  claim 1 , wherein the distal tip of the shaft is transverse to the longitudinal axis of the shaft and the first outlet of the first lumen is axially formed through the distal tip. 
     
     
         11 . The catheter of  claim 1 , wherein the second outlet is radially formed through the distal-end portion of the shaft. 
     
     
         12 . The catheter of  claim 1 , wherein the distal-end portion of the shaft includes an insertion section and an inflation section, wherein the balloon substantially surrounds the insertion section, and wherein the insertion section has a smaller diameter than the inflation section, which in turn has a smaller diameter than the main portion. 
     
     
         13 . The catheter of  claim 12 , wherein the second outlet is formed in the inflation section of the distal-end portion of the shaft. 
     
     
         14 . The catheter of  claim 12 , wherein the catheter can be guided forward until the balloon is positioned within the pilot opening in the tissue obstruction by advancing into the pilot opening the insertion section and the balloon but not the inflation section or the main portion of the shaft. 
     
     
         15 . The catheter of  claim 1 , wherein the second discharge outlet is radially formed through the main portion of the shaft or axially formed through a transition portion between the main portion and the distal-end portion of the shaft. 
     
     
         16 . A spinal catheter for inserting into an epidural space of a human or animal subject, the epidural space having a treatment area and a tissue obstruction, the catheter comprising:
 a shaft including a longitudinal axis, a distal-end portion having a distal tip that is transverse to the shaft axis, and a main extension portion positioned proximally relative to the distal-end portion, wherein the distal-end portion of the shaft has a smaller diameter than the main portion of the shaft, and wherein at least a portion of the shaft is flexible;   a first lumen extending through at least a portion of the shaft and including a first outlet axially formed in and transverse to the distal tip of the shaft, wherein the first lumen carries a first pressurized fluid and the first outlet discharges the first pressurized fluid directly onto the tissue obstruction to pressure-ablate at least a pilot opening therein;   a second lumen extending through at least a portion of the shaft and including a second outlet formed in the shaft, wherein the second lumen carries a second pressurized fluid and the second outlet discharges the second pressurized fluid; and   a distensible balloon positioned at the distal-end portion of the shaft, in fluid communication with the second lumen and the second outlet, and positionable within the pilot opening in the tissue obstruction, wherein the catheter can be guided forward until the balloon is positioned within the pilot opening by advancing into the pilot opening at least a portion of the distal-end portion and the balloon but not the main portion of the shaft, and wherein delivery of the second pressurized fluid into the balloon inflates the balloon within the pilot opening to radially compress the tissue obstruction to enlarge the pilot opening to form a final opening in the tissue obstruction through which the main portion of the shaft can pass so that the first outlet of the first lumen can be advanced to the treatment area in the epidural space,   wherein the first and second pressurized fluids can be delivered through the first and second lumens, respectively, to displace the tissue obstruction, and the catheter can be used to insert endoscopic surgical instruments, or to deliver or drain a third fluid, through the first lumen to or from the treatment area, all without removing and reinserting the catheter relative to the epidural space.   
     
     
         17 . The catheter of  claim 16 , wherein the distal-end portion of the shaft includes an insertion section and an inflation section, wherein the balloon substantially surrounds the insertion section and the second outlet is formed in the inflation section, and wherein the insertion section has a smaller diameter than the inflation section, which in turn has a smaller diameter than the main portion. 
     
     
         18 . The catheter of  claim 17 , wherein the catheter can be guided forward until the balloon is positioned within the pilot opening in the tissue obstruction by advancing into the pilot opening the insertion section and the balloon but not the inflation section or the main portion of the shaft. 
     
     
         19 . The catheter of  claim 16 , wherein the second discharge outlet is radially formed through the main portion of the shaft or axially formed through a transition portion between the main portion and the distal-end portion of the shaft. 
     
     
         20 . The catheter of  claim 16 , wherein the first pressurized fluid includes a saline solution, corticosteroid, and hyaluronidase, and wherein the second pressurized fluid comprises a sterilized fluid under sufficient pressure to inflate the balloon.